BioCentury | Nov 5, 2020
Management Tracks

Rosén joins Horizon as CSO and R&D head; plus moves at Boehringer, Dr. Reddy’s, Mylan and more

Karin Rosén joined Horizon Therapeutics plc (NASDAQ:HZNP) as CSO and EVP, research and development. She was SVP, U.S. medical affairs at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Boehringer Ingelheim appointed Yew Looi Liew as president of U.S. human pharma....
BioCentury | Sep 18, 2020
Product Development

Sept. 17 Quick Takes: Another Tecfidera setback for Biogen; plus ChemoCentryx PDUFA date and Amytrx’s debut

Tecfidera patent ruling another setback for BiogenThe U.S. District Court for the District of Delaware concluded that another court’s prior ruling invalidating a patent for Tecfidera dimethyl fumarate from Biogen Inc. (NASDAQ:BIIB) does apply under...
BioCentury | Sep 1, 2020
Product Development

Aug. 31 Quick Takes: Mylan, Biocon launch cheaper insulin in U.S.; plus: AZ, bluebird, Lipocine, Amgen, AbbVie-Morphic, Polyphor-Fosun and Milestone

Mylan, Biocon launch long-acting insulin biosimilar in U.S. Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:532523) launched Semglee insulin glargine in the U.S. at a wholesale acquisition cost (WAC) of $147.98 per package of five...
BioCentury | Aug 19, 2020
Product Development

Launch of generic Tecfidera puts more pressure on Biogen’s pipeline

The introduction of generic competition in the U.S. for MS blockbuster Tecfidera, which accounted for 40% of Biogen’s product revenue last half, puts increased pressure on the remainder of big biotech’s pipeline.  On Wednesday, Mylan...
BioCentury | Aug 19, 2020

Momenta’s shift to innovative pipeline pays off with $6.5B J&J takeout

Momenta’s 2018 decision to reorganize its business around its innovative pipeline was the critical step that positioned the biotech for its $6.5 billion takeout by J&J, announced Wednesday. The company had deprioritized its complex generics...
BioCentury | Jul 10, 2020
Product Development

Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer...
BioCentury | Jul 6, 2020
Product Development

U.K. may be near 60M dose deal with Sanofi, GSK for second COVID-19 vaccine partnership

The U.K. is reportedly in talks to secure access to a second COVID-19 vaccine, this time from GlaxoSmithKline and Sanofi, as concerns grow over vaccine nationalism. The government has already partnered with AstraZeneca plc (LSE:AZN;...
BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | Jun 12, 2020

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...
BioCentury | May 13, 2020
Product Development

Gilead secures global access to remdesivir via generic manufacturing deals

The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic. Gilead Sciences Inc....
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